NCT07146152

Empowering Women - Shared Decision Making in Managing Cervical Precancer

Empowering Women - Shared Decision-Making in Managing Cervical Precancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of this stepped-wedge randomized clinical trial is to assess the impact of implementing a patient decision aid during consultations with patients diagnosed with cervical precancer. Specifically, it will evaluate whether the decision aid enhances shared decision-making, improves the patient experience, and influences their treatment preferences. The main questions this study aims to answer are: 1. Will the implementation of the patient decision aid increase the number of patients with cervical precancer who opt for surgery (loop electrical excision) compared to active surveillance? 2. Will the implementation of the patient decision aid improve patients' experience with the course of treatment for cervical precancer? To evaluate this, researchers will compare patients receiving counseling with the support of the decision aid to those receiving standard counseling without the decision aid. After the consultation, participants will complete questionnaires to share their experience. Data on treatment choices will be gathered from patient medical records.

Conditions

• CIN2

Interventions

Type	Name	Description
DEVICE	Patient Decision Aid	A Patient Decision Aid designed to help patients with CIN2 make informed decisions about wether they prefer operation (Loop Electrical Surgery) or active surveillance.

Timeline

• Start date: 2025-10-01
• Primary completion: 2030-04-30
• Completion: 2030-04-30
• First posted: 2025-08-28
• Last updated: 2025-08-28

Locations

1 site across 1 country: Denmark